Cleared Traditional

K082278 - MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS

K082278 is an FDA 510(k) clearance for MAMMOMARK, manufactured by Ethicon Endo-Sugery, LLC. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K082278 · Ethicon Endo-Sugery, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
127d
Days
Class 2
Risk

K082278 is an FDA 510(k) clearance for the MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Ethicon Endo-Sugery, LLC (Cincinnati, US). The FDA issued a Cleared decision on December 16, 2008 after a review of 127 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Ethicon Endo-Sugery, LLC devices

FDA 510(k) Submission Details - K082278

510(k) Number K082278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2008
Decision Date December 16, 2008
Days to Decision 127 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 115d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NEU Device Classification - Class 2, Special Controls

Product Code NEU Marker, Radiographic, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - NEU Marker, Radiographic, Implantable

All 73
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K082278.
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K080698 · Senorx, Inc. · Mar 2008